Rilpivirine Food PK Study

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201301000480567
• Date of registration: 07/01/2013
• Primary sponsor: Infectious Diseases Institute, Makerer University College of Health Sciences
• Public title: Rilpivirine Food PK Study
• Scientific title: EFFECT OF FOOD ON THE STEADY-STATE PHARMACOKINETICS OF RILPIVIRINE WHEN ADMINISTERED AS A FIXED-DOSE COMBINATION IN HIV-1 INFECTED UGANDAN ADULTS
• Date of first enrolment: 2013-02-01
• Target sample size: 15
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201301000480567
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Michael Enyakoit
• Affiliation: Regulatory Officer / Infectious Diseases Institute

• Name: Mohammed Lamorde
• Affiliation: Research Fellow / Infectious Diseases Institute

Key inclusion & exclusion criteria

Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Aged between 18 to 65 years, inclusive.
4. Diagnosed with HIV-1 infection
5. Receiving first-line ART containing tenofovir disoproxil fumarate, efavirenz plus either emtricitabine or lamivudine for a minimum of 6 months

Exclusion criteria: 1. HIV-1 RNA b 400 copies/mL at screening visit
2. Serum hemoglobin ` 8g/dl
3. Elevations in serum levels of alanine transaminase (ALT), aspartate transaminase (AST) or creatinine above 3 times the upper limit of normal
4. Evidence of QT prolongation on electrocardiogram (ECG) QTc (Rate adjusted QT interval) b450ms (men) or b470ms (women)
5. History of cardiac disease
6. Diarrhea lasting greater than one week
7. Use of known inhibitors or inducers of CYP3A4 .
8. Use of antacids, histamine-2 blockers or proton pump inhibitors
9. Use of herbal medications (information will be obtained from patients? medication history through interview with the patient)
10. Consumption of grapefruit within 1 week of first dose of study drug and for the duration of the study
11. Pregnant or lactating females
12. Participation in other clinical studies within four weeks before the current study begins and/or during study participation. Subjects should not be concurrently enrolled in another clinical trial.


Age minimum: 18 Year
Age maximum: 65 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

Steady-state plasma concentrations of rilpivirine

Secondary Outcome(s)

Short-term safety and tolerability of Complera? in HIV-1 infected patients

Secondary ID(s)

HS 1262

PK-08

Source(s) of Monetary Support

Janssen Pharmaceutica